Proposed Process Improvements from EPA

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

Registration Division's New Process

The following outline five new processes that RD has developed and is implementing:

Process for Fast Track Actions

Schedule for Non-Fast Tracks

Schedule for New Use (Not First Food Use)

Schedule for New Active Ingredient/First Food Use

IR-4 Application Process

The first process, relating to fast track actions, is in the form of a detailed narrative. Please note that the instructions for negotiating due dates that are contained here apply specifically to these short-turn around (90-day) actions and would not necessarily apply or be used in other situations.

The next three processes are in the form of project management schedules that the risk managers will be using to organize, schedule and track the work on non-fast tracks, new uses, and new a.i.’s.

Finally, we have included a summary of the new requirements for an IR-4 application.

If failed 86-5 begin calls to resolve 86-5 problems; if possible do completeness check and
use calls to resolve completeness issues also

When action passes 86-5 and completeness check send to TRB

However, if 86-5 problems cannot be resolved quickly or the package is substantially incomplete and cannot be corrected quickly (by the day the clock starts, i.e. within approximately 10 days), then:

If you believe the package can be completed in a reasonable amount of time:

Fill out the form for DD/OD review recommending that a time extension be negotiated that will be
the number of days from when you place a call to the registrant stating what needs to be sent in to
correct/complete the package until that information comes in, is correct, and has been through
in-processing.

While the recommendation is being reviewed, write letter stating deficiencies and prepare to call
registrant to negotiate the new date.

When you receive go-ahead on recommendation or different instruction-then proceed to handle
the action accordingly.

You must get written agreement from the registrant on the renegotiated due date (standard
template letter can be provided in OPPIN–we are working on a draft). This letter will state
that the number of days that will be added to the clock will reflect the number of days from when
the registrant was notified of the deficiencies (state that date) until the information arrives in
the Agency, is correct, and is ready for review. It should further state that the Agency will call
the registrant when this happens to inform them of what the date is.*

OPPIN can also scan-in registrant responses so that a permanent record is easily available.

Always enter information on the new due date and the reason it was extended into OPPIN. When the
package passes 86-5 and the completeness check send it to TRB or repeat this step as necessary or
until move to 2 below!

If you believe the package cannot be completed in a reasonable amount of time with a reasonable
amount of effort, fill out the form for DD/OD review recommending that the action be denied and
explaining why.

When you receive go-ahead on your recommendation or different instruction–then
proceed to handle action accordingly.

Always enter the information that the submission was denied and the reason into OPPIN.

III. TRB

TRB will receive packages that have passed 86-5 and are judged to be complete by the PM
teams. According to II. above, the PM teams will have taken no more than 21 days after the
pin-punch date or the date of receipt of payment, whichever is later to accomplish this unless
they have negotiated a new due date to account for the time it has taken the registrant to remedy
any deficiencies. Thus, the clock should have 90 days remaining when the action arrives in TRB.

TRB review

If no further issues arise, e.g. with data deficiencies, TRB will complete its review and
return the action to the PM team within 45 days.

If minor problems arise that can be resolved quickly (within a week–total for all
minor problems on one action), TRB will resolve these problems and get reviews done within the
45 days.

If problems arise that cannot be resolved quickly as described in 2 above, e.g. entire
studies are missing, the action will be referred back to the PM team for resolution and negotiation
of a new due date. In these cases TRB will return copies of the standard completeness checklist with
notes to the risk manager concerning what the deficiencies are.

In cases where problems arise after the TRB review is done, TRB should write up the review
and provide it to the risk manager along with a statement of the problem to be resolved.

IV. PM Team

If the TRB review is complete, the PM team will get the action out by the due date.

If TRB has referred a problem package back to the PM team

If the PM team believes the problems can be solved in a reasonable amount of time
they will proceed as in II. E. 1 until such time as the package can be returned to TRB with the
problems corrected and a new negotiated due date that reflects the time it took to get the problems
resolved.

If the PM team believes the problems cannot be resolved in a reasonable amount of time the PM
team will proceed as in II. E. 2 and recommend the package be denied.

* We propose that IRSD develop a separate in-processing queue for items that are corrections/ additions to already submitted actions, so that these (presumably small) actions may move quickly through in-processing. If this were the case, we could have registrants use a code that would indicate this was in that category and they might be less concerned about the in-processing time. [Note: This has been done.]

New Procedures for an Application Associated with an IR-4 Tolerance Petition

Given the emphasis of PRIA on the Agency’s review time frames, EPA is placing a special focus on working with applicants to ensure that all registration applications are correct, complete and ready for review. When this is the case, the review and decision making processes can begin immediately and be completed without the loss of efficiency involved in starting and stopping work and waiting for corrections or additional information.

On this point, submissions from IR-4 are no different but can be considered a unique category, since their researchers typically develop the tolerance petition EPA considers in evaluating a food use registration application. However, IR-4 is not a chemical producer but works in collaboration with pesticide manufacturers and producers on minor crops. EPA is requesting that the data packages for IR-4 uses contain all of the necessary elements for the Agency’s consideration as would be needed for a registrant-generated submission. Notably, EPA intends to process and review the tolerance petition (i.e. IR-4's portion) concurrently with the registrant’s registration application and label.

Therefore, in order to receive tolerance petitions and registration applications which are complete and ready for Agency review, applications from IR-4 should contain:

The tolerance petition

Notice of Filing

The completed application for registration (8570-1 form)

Letter of authorization from the registrant which permits EPA to rely on their data

All supporting data and labels

Adherence to this submission format will help to ensure that IR-4-company actions can be completed in the time frames called for under PRIA.